Myocardial InfarctionPhase 2LowASA-PCINCT06254391
Aspirin Dose Comparison in Elderly PCI Patients: 30mg vs. 75mg in Acute Coronary Syndrome
A Phase 2 study testing Low-dose aspirin in people with Myocardial Infarction and Acute Coronary Syndrome, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Elderly patients undergoing percutaneous coronary intervention (PCI) face a high risk of both ischemic and hemorrhagic complications necessitating antiplatelet therapy. Previous data indicate that even at a dose of 20-30 mg/day, aspirin (ASA) allows almost complete inhibition of thromboxane (TX) A2 biosynthesis in… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, Acute Coronary Syndrome
- What is being tested?
- Low-dose aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 3 Jul 2023to Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age above 65 years
- acute coronary syndrome (ACS)
- positive results for myocardial necrosis markers (troponins)
- undergoing successful coronary angioplasty with stent implantation within the last 24-48 hours before enrollment in the study
- dual antiplatelet therapy (DAPT) containing ticagrelor
Who cannot join
- indications other than ACS and PCI for DAPT use
- history of stent thrombosis during the course of DAPT
- planned subsequent coronary artery revascularization
- planned surgery requiring suspension or interruption of DAPT
- planned discontinuation of ASA or P2Y12 antagonist during the study
- use of doses other than 75 mg ASA once daily or non-use of a P2Y12 inhibitor - intake of diuretic drugs (e.g., loop diuretics, thiazides, potassium-sparing drugs)
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- intake or planned intake of oral anticoagulants, parenteral antithrombotic therapy (e.g., unfractionated heparin, low molecular weight heparin, bivalirudin), glycoprotein IIb/IIIa inhibitors (e.g., abciximab, tirofiban), fibrinolytic agents (e.g., tissue plasminogen activator), or nonsteroidal anti-inflammatory drugs
- history of acute or chronic liver disease; severe kidney disease requiring dialysis; pregnancy; comorbidities associated with a predicted life expectancy of less than 1 year
- any other condition deemed by the investigator to impact hemostasis, coagulation, bleeding risk, or the ability to adhere to the study protocol; receiving a strong inhibitor of cytochrome P450 3A, simvastatin or lovastatin at doses greater than 40 mg per day, a narrow therapeutic index cytochrome P450 3A substrate (e.g., cyclosporine or quinidine), or a strong inducer of cytochrome P450 3A (e.g., rifampin, rifabutin, phenytoin, carbamazepine, phenobarbital)
- hemodynamic instability; clinical condition preventing obtaining informed consent.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
1st Department and Clinic of Cardiology, Medical University of Warsaw
Warsaw, Mazowieckie Voivodenship, 02-097
Mariusz Tomaniak, PhD, +48 22 599-19-58, mariusz.tomaniak@wum.edu.pl
Mariusz Tomaniak, PhD
About this study
Official title: Very Low-dose Aspirin (30mg) vs. Standard Low-dose Aspirin (75mg) Among Patients Aged 65 Years or Above Undergoing PCI for Acute Coronary Syndrome: an Open-label Randomized Crossover Design Trial.
Elderly patients undergoing percutaneous coronary intervention (PCI) face a high risk of both ischemic and hemorrhagic complications necessitating antiplatelet therapy. Previous data indicate that even at a dose of 20-30 mg/day, aspirin (ASA) allows almost complete inhibition of thromboxane (TX) A2 biosynthesis in healthy volunteers. However, ASA at a dose of 30 mg/day has not been evaluated in the acute phase of myocardial infarction or among elderly patients, where it may achieve an optimal balance between bleeding risk and ischemic complications.
This randomized study will include 40 patients over 65 years undergoing PCI for acute coronary syndrome (ACS). It compares a new dual antiplatelet therapy (DAPT) strategy consisting of a P2Y12 antagonist (ticagrelor) and ASA at a very low dose of 30 mg/day (n=20) against the current standard treatment (P2Y12 antagonist and ASA at a dose of 75 mg) (n=20) in the control group.
- Conditions
- Myocardial Infarction, Acute Coronary Syndrome
- Being tested
- Low-dose aspirin
- Keywords
- Dual Antiplatelet Therapy, Myocardial Infarction, Acute Coronary Syndrome, Very-low dose aspirin, PCI
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose aspirinDrug
Implementation of low-dose aspirin (30 mg)
| Study group | Role | What they receive |
|---|---|---|
| Very low-dose aspirin first | Other | Patients will receive ASA 30mg per day (in the morning) for 14 days, followed by ASA 75mg per day (in the morning) for the next 14 days.
All the participants will receive standard maintenance dose of ticagrelor 90mg twice a day as part of the DAPT therapy. All the participants will receive the loading dose of ASA 300mg before the PCI procedure. Receives: Drug: Low-dose aspirin |
| Standard low-dose aspirin first | Other | Patients will receive ASA 75mg per day (in the morning) for 14 days, followed by ASA 30mg per day (in the morning) for the next 14 days.
All the participants will receive standard maintenance dose of ticagrelor 90mg twice a day as part of the DAPT therapy. All the participants will receive the loading dose of ASA 300mg before the PCI procedure. Receives: Drug: Low-dose aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity (ASPI)
Comparison of platelet reactivity dependent on arachidonic acid (ASPI test) in low-dose ASA therapy, assessed in impedance aggregometry in regards to group treated with DAPT with standard ASA 75mg dose after 14 days of therapy.
Measured: 14th day of treatment, 2h before ASA 30mg dose (through effect), and 2h after ASA 30mg dose (peak effect), in regards to group treated with DAPT with standard ASA 75mg dose after 14 days of therapy
Secondary outcomes (6)
Platelet reactivity (ADP)
Comparison of platelet reactivity dependent on ADP (ADP test) in low-dose ASA therapy, assessed in impedance aggregometry in regards to the group treated with DAPT with standard ASA 75mg dose and level changes in individual patients.
Measured: Days 7, 14, and 28 of treatment, 2 hours before the administration of the next ASA dose (pre-dose - representing the trough effect), and 2 hours after the ASA dose (post-dose - representing the peak effect)
Platelet reactivity (TRAP-6)
Comparison of platelet reactivity dependent on TRAP-6 protein activating the thrombin receptor (TRAP test) in low-dose ASA therapy, assessed in impedance aggregometry in regards to group treated with DAPT with standard ASA 75mg dose and level changes in individual patients.
Measured: Days 7, 14, and 28 of treatment, 2 hours before the administration of the next ASA dose (pre-dose - representing the trough effect), and 2 hours after the ASA dose (post-dose - representing the peak effect)
Platelet reactivity (ASPI)
Comparison of platelet reactivity dependent on arachidonic acid (ASPI test) in low-dose ASA therapy, assessed in impedance aggregometry in regards to group treated with DAPT with standard ASA 75mg dose and level changes in individual patients.
Measured: Days 7, and 28 of treatment, 2 hours before the administration of the next ASA dose (pre-dose - representing the trough effect), and 2 hours after the ASA dose (post-dose - representing the peak effect)
Bleeding time
Comparison of bleeding time (assessed with lancet method) between two groups (ASA 30mg and ASA 75mg) and among the individual patients.
Measured: Days 7, 14, and 28 of treatment 2 hours after the administration of the ASA dose
PGI2 levels
Comparison of PGI2 concentration in urine between two groups (ASA 30mg and ASA 75mg) and among the individual patients.
Measured: Measured on days 7, 14, and 28 of treatment, 2 hours after the administration of the ASA dose
TXB2 levels
Comparison of TXB2 concentration between two groups (ASA 30mg and ASA 75mg) and among the individual patients.
Measured: Days 7, 14, and 28 of treatment, 2 hours before the administration of the next ASA dose, and 2 hours after the ASA dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start3 Jul 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- After collecting basic clinical information about the patients, patients undergoing percutaneous coronary intervention (PCI) due to acute coronary syndrome (within 24-48 hours after the procedure) will be randomized in a 1:1 scheme using the mobile application "Randomizer for Clinical Trial" (Medsharing, France) to one of the two arms of the study receiving ticagrelor at a maintenance dose of 90 mg twice daily, in which the following treatment sequence will be used (open-label crossover design): 1. Aspirin (ASA) 30 mg once daily (morning) for 14 days followed by ASA 75 mg once daily (morning) for 14 days or 2. ASA 75 mg once daily (morning) for 14 days, then ASA 30 mg once daily (morning) for 14 days. All patients will receive a loading dose of aspirin 300 mg before PCI
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariusz Tomaniak, Medical University of Warsaw
- Investigators
- Mariusz Tomaniak, PhD, Principal investigator, 1st Department and Clinic of Cardiology, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254391
- Sponsor's protocol ID
- LowASA-PCI
- Acronym
- LowASA-PCI
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Very Low-dose Aspirin (30mg) vs. Standard Low-dose Aspirin (75mg) Among Patients Aged 65 Years or Above Undergoing PCI for Acute Coronary Syndrome: an Open-label Randomized Crossover Design Trial.
- ClinicalTrials.gov ID
- NCT06254391
- Acronym / sponsor ID
- LowASA-PCI / LowASA-PCI
- Conditions
- Myocardial Infarction, Acute Coronary Syndrome
- Keywords
- Dual Antiplatelet Therapy, Myocardial Infarction, Acute Coronary Syndrome, Very-low dose aspirin, PCI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Elderly patients undergoing percutaneous coronary intervention (PCI) face a high risk of both ischemic and hemorrhagic complications necessitating antiplatelet therapy. Previous data indicate that even at a dose of 20-30 mg/day, aspirin (ASA) allows almost complete inhibition of thromboxane (TX) A2 biosynthesis in healthy volunteers. However, ASA at a dose of 30 mg/day has not been evaluated in the acute phase of myocardial infarction or among elderly patients, where it may achieve an optimal balance between bleeding risk and ischemic complications.
This randomized study will include 40 patients over 65 years undergoing PCI for acute coronary syndrome (ACS). It compares a new dual antiplatelet therapy (DAPT) strategy consisting of a P2Y12 antagonist (ticagrelor) and ASA at a very low dose of 30 mg/day (n=20) against the current standard treatment (P2Y12 antagonist and ASA at a dose of 75 mg) (n=20) in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After collecting basic clinical information about the patients, patients undergoing percutaneous coronary intervention (PCI) due to acute coronary syndrome (within 24-48 hours after the procedure) will be randomized in a 1:1 scheme using the mobile application "Randomizer for Clinical Trial" (Medsharing, France) to one of the two arms of the study receiving ticagrelor at a maintenance dose of 90 mg twice daily, in which the following treatment sequence will be used (open-label crossover design): 1. Aspirin (ASA) 30 mg once daily (morning) for 14 days followed by ASA 75 mg once daily (morning) for 14 days or 2. ASA 75 mg once daily (morning) for 14 days, then ASA 30 mg once daily (morning) for 14 days. All patients will receive a loading dose of aspirin 300 mg before PCI
| Arm | Type | Receives |
|---|---|---|
| Very low-dose aspirin first | Other | Drug: Low-dose aspirinPatients will receive ASA 30mg per day (in the morning) for 14 days, followed by ASA 75mg per day (in the morning) for the next 14 days. All the participants will receive standard maintenance dose of ticagrelor 90mg twice a day as part of the DAPT therapy. All the participants will receive the loading dose of ASA 300mg before the PCI procedure. |
| Standard low-dose aspirin first | Other | Drug: Low-dose aspirinPatients will receive ASA 75mg per day (in the morning) for 14 days, followed by ASA 30mg per day (in the morning) for the next 14 days. All the participants will receive standard maintenance dose of ticagrelor 90mg twice a day as part of the DAPT therapy. All the participants will receive the loading dose of ASA 300mg before the PCI procedure. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- age above 65 years
- acute coronary syndrome (ACS)
- positive results for myocardial necrosis markers (troponins)
- undergoing successful coronary angioplasty with stent implantation within the last 24-48 hours before enrollment in the study
- dual antiplatelet therapy (DAPT) containing ticagrelor
Key exclusion criteria (10 listed)
- indications other than ACS and PCI for DAPT use
- history of stent thrombosis during the course of DAPT
- planned subsequent coronary artery revascularization
- planned surgery requiring suspension or interruption of DAPT
- planned discontinuation of ASA or P2Y12 antagonist during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose aspirinImplementation of low-dose aspirin (30 mg) | Drug | Standard low-dose aspirin first, Very low-dose aspirin first |
Primary outcome
Platelet reactivity (ASPI)
Time frame: 14th day of treatment, 2h before ASA 30mg dose (through effect), and 2h after ASA 30mg dose (peak effect), in regards to group treated with DAPT with standard ASA 75mg dose after 14 days of therapy
Comparison of platelet reactivity dependent on arachidonic acid (ASPI test) in low-dose ASA therapy, assessed in impedance aggregometry in regards to group treated with DAPT with standard ASA 75mg dose after 14 days of therapy.
6 secondary outcomes
Platelet reactivity (ADP)
Time frame: Days 7, 14, and 28 of treatment, 2 hours before the administration of the next ASA dose (pre-dose - representing the trough effect), and 2 hours after the ASA dose (post-dose - representing the peak effect)
Platelet reactivity (TRAP-6)
Time frame: Days 7, 14, and 28 of treatment, 2 hours before the administration of the next ASA dose (pre-dose - representing the trough effect), and 2 hours after the ASA dose (post-dose - representing the peak effect)
Platelet reactivity (ASPI)
Time frame: Days 7, and 28 of treatment, 2 hours before the administration of the next ASA dose (pre-dose - representing the trough effect), and 2 hours after the ASA dose (post-dose - representing the peak effect)
Bleeding time
Time frame: Days 7, 14, and 28 of treatment 2 hours after the administration of the ASA dose
PGI2 levels
Time frame: Measured on days 7, 14, and 28 of treatment, 2 hours after the administration of the ASA dose
TXB2 levels
Time frame: Days 7, 14, and 28 of treatment, 2 hours before the administration of the next ASA dose, and 2 hours after the ASA dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariusz Tomaniak, PhD principal investigator
1st Department and Clinic of Cardiology, Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low-dose aspirin in people with Myocardial Infarction and Acute Coronary Syndrome, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariusz Tomaniak, PhD (+48 22 599-19-58, mariusz.tomaniak@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet reactivity (ASPI) (time frame: 14th day of treatment, 2h before ASA 30mg dose (through effect), and 2h after ASA 30mg dose (peak effect), in regards to group treated with DAPT with standard ASA 75mg dose after 14 days of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.